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Proposal Made to Make Nanomaterials Subject to New Notification Requirements in Sweden

19 August 2016

Pursuant to a new proposal from the Swedish Chemicals Agency (the SCA), new measures concerning nanomaterials should be entering into force on 1 January 2018. The SCA has published a report in which it proposes to introduce new notification requirements for the use of nanomaterials in chemical products. The SCA’s proposal will be subject to consultation during autumn 2016, at the end of which the SCA will notify the proposal to the European Commission.

The new report from the SCA follows an initiative by the Swedish Government in 2015, in which the SCA was commissioned to investigate a way of coming up with a reporting requirement for the provision of information on nanomaterials in chemical products and articles in the Swedish products register (for more on the existing products register see below, at the end of this article). In the report, the SCA notes that the development of new nanomaterials is occurring quickly and that the industry is growing rapidly. However, some nanomaterials, unlike the same material in other sizes, have been shown to have negative effects on health and the environment.

More specifically, the SCA proposes that those who report chemical products to the products register shall, in addition to the information that is currently reported, also provide further information regarding any nanomaterials contained in the product. In order to identify and distinguish nanomaterials, the SCA considers that information on:

(i) the physical appearance; (ii) the chemical composition and structure; and (iii) the surface’s physical and chemical structure

is required in the notification to the products register.

The proposal only covers nanomaterials which have been intentionally added to the product, regardless of concentration. Thus, the proposal does not cover nanomaterials that are naturally occurring or unintentionally produced.

The SCA further proposes to introduce, during a period of evaluation, an exception to the notification requirement for companies with an annual turnover of less than SEK 5 million. According to the SCA, these companies should only need to tick a box if they believe that their products contain nanomaterials. In addition, the SCA proposes that the product groups that are already exempt from the reporting requirements in the Products Register, such as waste, food and animal feed, pharmaceuticals, cosmetics and tattoo ink, will remain exempt from the scope of the present proposal.

The SCA notes that the aim of the proposed measures is to create an overview of the nanomaterials used in Sweden, e.g. for the purpose of keeping statistics on the use of nanomaterials. These statistics can then be used as a basis for future regulatory developments within the spheres of environment, health and safety.

The Swedish Agency does not propose any reporting requirements for nanomaterials in articles as a part of this report. It is however suggested that such reporting requirements may be studied in a separate investigation. Several European countries have currently introduced, or are planning to implement, their own solutions for gathering information regarding nanomaterials on their own markets. There is also an ongoing study within the European Commission regarding the possibility of introducing a joint EU repository for nanomaterials.

As regards the already-existing notification requirement, Hong Kong traders may be familiar with the currently applicable Swedish products register. This is a register where the Swedish Chemicals Agency gathers and stores information on chemical products and biotechnical organisms that are manufactured in or imported into Sweden, and information on the ways in which these are being used. Thus, companies that manufacture in or import products into Sweden that are covered by the notification requirement, must notify the Swedish Agency at the latest when they start their business.

Notifiable chemical products are those products whose customs tariff numbers are on the list of customs numbers in Annex 1 of the Chemical Products and Biotechnical Organisms Ordinance. See the SCA's website for further information. The notification can be done by using the forms made available via the website for forms.